Evaluation of the Clinical Impact of Different Telemedicine Practices in Intensive Care Units: a Stepped-wedge Cluster Randomized Clinical Trial (TELESCOPE 2): study protocol

ABSTRACT BACKGROUND The safety and feasibility of telemedicine in intensive care units (ICU) are well established. However, whether tele-ICU exerts a measurable impact on clinically relevant outcomes remains uncertain. METHODS AND ANALYSIS The TELESCOPE 2 is a multicenter, open-label, stepped-wedge cluster randomized controlled trial including 25 ICUs in Brazil from January 2024 to January 2026. In a stepped-wedge assignment, ICUs will be randomized and allocated into one of five sequences. All ICUs will receive the interventions staggered at different times. All adult patients admitted in participant ICUs will be eligible for inclusion in the study. Admissions for non-medical reasons, and patients previously included in the TELESCOPE 2 study will be excluded. The trial intervention is multifaceted, comprising three components delivered in combination, via telemedicine: i) daily multidisciplinary rounds led by board-certified intensive care physicians; ii) coordinated care by a multidisciplinary team, including nurses, physiotherapists, and clinical pharmacists); iii) a management strategy focused on quality improvement and patient safety. The primary outcome is ICU length of stay. Secondary outcomes include ICU mortality, in-hospital mortality, ventilator-free days during the first 28 days, ICU readmission within 48 hours, early reintubation, ventilator-associated events, and accidental extubation rate. ETHICS AND DISSEMINATION This study was approved by the Institutional Review Board of the Einstein Hospital Israelita (CAAE: 69575123.0.1001.0071), and each participating center’s ethics committee. The study results will be published in peer-reviewed journals and disseminated at international conferences. TRIAL REGISTRATION Clinicaltrials NCT05960994 , Brazilian Registry of Clinical Trials RBR-342wxn9, and Universal Trial Number U1111-1298-9799.